MoonLake Submits BLA for Sonelokimab in Hidradenitis Suppurativa

MoonLake Immunotherapeutics, a clinical-stage biotechnology company focused on developing next-level therapies for inflammatory diseases, has made significant strides in its research and development pipeline. The company recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for sonelokimab, an investigational Nanobody® for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. This submission marks an important step towards potential U.S. approval and commercialization.

In August 2026, MoonLake reported positive Week 16 results from the Phase 3 IZAR-1 trial in psoriatic arthritis (PsA). The primary endpoint analysis showed that 42.1% of biologic-naïve patients treated with sonelokimab 60 mg with induction achieved an American College of Rheumatology 50 (ACR50) response at Week 16. This result is a significant milestone in the company's efforts to bring sonelokimab to market.

MoonLake also completed enrollment in the Phase 3 IZAR-2 trial in PsA in September 2026. Initial topline results from this trial are expected in the first quarter of 2027, following the predefined unblinding protocol. Additionally, the company is on track to start enrollment in the Phase 3 NOVA trial for palmoplantar pustulosis (PPP) in November 2026.

Financially, MoonLake ended the third quarter of 2026 with $498.5 million in cash, cash equivalents, and short-term marketable debt securities. The company expects to have a cash runway to mid-2028, with up to $400 million in non-dilutive funds remaining available through its debt facility with Hercules Capital. Research and development expenses for the quarter were $68.9 million, an increase of $18.7 million from the previous quarter, primarily due to accrued milestone license fees for a regulatory milestone associated with the expected acceptance of the Company's BLA submission. General and administrative expenses were $11.0 million for the quarter, down slightly from $11.4 million in the previous quarter.

The company is expected to receive a decision on BLA filing acceptance by the end of November 2026 and a Prescription Drug User Fee Act (PDUFA) goal date by mid-December 2026. MoonLake is also anticipated to present year 1 VELA OLE data in the second half of 2027 and commence enrollment for the NOVA Phase 3 trial in November 2026.

MoonLake Immunotherapeutics, founded in 2021 and headquartered in Zug, Switzerland, is unlocking the potential of sonelokimab to revolutionize outcomes for patients with inflammatory diseases. Sonelokimab, an investigational ~40 kDa humanized Nanobody®, selectively binds with high affinity to IL-17A and IL-17F, inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company is pursuing other indications in dermatology and rheumatology, including adolescent HS, PPP, and axial spondyloarthritis.